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PF-08634404 with Chemotherapy for Extensive-Stage Small Cell Lung Cancer

This study is looking into a new medicine called PF-08634404, given along with chemotherapy, for adults with extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a fast-growing type of lung cancer that has spread widely. The study aims to see how safe PF-08634404 is and how well people tolerate it, as well as how effective it is at shrinking tumors (Objective Response Rate) and improving overall survival. You might be able to join if you are 18 or older, have ES-SCLC confirmed by tests, and haven't had chemotherapy or radiation for this condition before. The study plans to enroll about 550 participants.

Study design
This interventional study is designed to learn about PF-08634404 in combination with chemotherapy. It plans to enroll 550 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 2 years after completing study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07226999

Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Pfizer
~550 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:PF-08634404AtezolizumabChemotherapy

At a glance

Recruiting sites
59 of 83 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 2: Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] based on the investigator's assessment
Measured over Up to approximately 2 years after completion of study treatment of last study participant
+2 more outcomes measured

Conditions

Small Cell Lung Cancer (SCLC)

Explore related trials

Lung Small Cell Carcinoma

Where it's being run

83 sites across 24 states
Texas37
Virginia11
Puerto Rico4
Spain4
Arkansas3
Florida3
Taiwan3
Germany2

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
Participants have not received systemic therapy (chemotherapy, radiotherapy, chemoradiation) for ES-SCLC.
Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
Have at least one measurable lesion as the targeted lesion based on RECIST V1.1.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Adequate organ function

Exclusion

known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
Leptomeningeal disease
Clinically significant risk of hemorrhage or fistula
history of another malignancy within 3 years
active autoimmune diseases requiring systemic treatment within the past 2 years

What this trial measures

  • Phase 2: Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] based on the investigator's assessmentUp to approximately 2 years after completion of study treatment of last study participant

    Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response. ORR using RECIST v1.1 as assessed by investigator.

  • Phase 2: Number of participants with treatment-emergent adverse eventsUp to 90 days after the last dose of treatment

    Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.

  • Phase 3: Overall Survival (OS)Up to approximately 2 years after completion of study treatment of last study participant

    OS is defined as the time from the date of randomization to the date of death due to any cause. OS is secondary outcome measure in Phase 2 portion of the study.